| Date Initiated by Firm | May 23, 2023 |
|---|
| Date Posted | June 08, 2023 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1697-2023 |
|---|
| Recall Event ID |
92401 |
| 510(K)Number | K153334 |
|---|
| Product Classification |
Varnish, cavity - Product Code LBH
|
| Product | BencoDental iris 5% NaF varnish, WHITE MINT ITEM # 4323-635; cavity varnish |
|---|
| Code Information |
UDI/DI 00366975000590, Lot number 207540, Exp. 20240930 |
| FEI Number |
1941138
|
Recalling Firm/
Manufacturer |
Young Dental Manufacturing I, LLC
13705 Shoreline Ct E
Earth City MO 63045-1202
|
| For Additional Information Contact | Jose Espino
224-622-7191 |
|---|
Manufacturer Reason
for Recall | The Iris 5% Fluoride Varnish White Mint package lot 207540 may contain units of 5% Fluoride Varnish Bubblegum. |
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FDA Determined
Cause 2 | Employee error |
|---|
| Action | Young Dental notified the single customer via certified mail on 05/23/2023. The customer was instructed to discard or return the affected product and complete and return the response form. |
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| Quantity in Commerce | 344 boxes |
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| Distribution | US distribution to Florida, Nevada, and Pennsylvania. |
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| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = LBH
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